search
Back to results

Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

Primary Purpose

Cervical Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cervical TDR
ACDF with plate
Sponsored by
DePuy Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Degenerative Disc Disease focused on measuring cervical, spinal, arthroplasty, disc, surgical, ACDF, DDD

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
  • Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
  • Moderate Neck Disability Index (NDI) score
  • Able to give informed consent for study participation
  • Able and willing to return for all follow-up visits

Key Exclusion Criteria:

  • Significant cervical degenerative disc disease
  • Prior fusion procedure at any level(s) (C1-T1)
  • Marked cervical instability on lateral or flexion/extension radiographs
  • Presence of systemic infection or infection at the surgical site
  • Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
  • History of alcohol and/or drug abuse
  • Any known allergy to a metal alloy or polyethylene
  • Morbid obesity
  • Any significant general illness (e.g., metastatic cancer, HIV)

Sites / Locations

  • Olympia Medical Center
  • Sutter Medical Center
  • Rocky Mountain Associates in Orthopedic Medicine, PC
  • Yale University
  • Florida Orthopaedic Institute
  • Emory Orthopaedics and Spine Center
  • Rush University/Midwest Orthopaedics
  • Northwestern Medical Faculty Foundation
  • Johnson County Spine
  • University of Kentucky
  • Johns Hopkins University
  • Boston Spine Group
  • University of Michigan
  • Borgess Medical Center
  • William Beaumont Hospital
  • Twin Cities Spine
  • St. John's Regional Medical Center
  • St. Patrick Hospital Neurological Associates
  • Nebraska Spine Center, LLC
  • Center for Diseases and Surgery of the Spine
  • University of Medicine and Dentistry of New Jersey
  • Southern NY Neurosurgical Group
  • Upstate Medical College/SUNY
  • Carolina Neurosurgery & Spine Associates
  • Triangle Orthopaedic Associates
  • Neurospine Institute
  • North Texas Spine Care at Baylor Health
  • Texas Back Institute
  • University of Utah
  • University of Virginia
  • Pacific Private Clinic
  • St. Elisabeth Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

1-level Cervical TDR

1-level ACDF with plate

2-level Cervical TDR

2-level ACDF

Training: 1 & 2-level Cervical TDR

Arm Description

Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.

Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.

Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.

Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.

Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.

Outcomes

Primary Outcome Measures

Overall Success
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.

Secondary Outcome Measures

NDI Success
15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Neurological Component of Success
no new clinically significant permanent abnormalities in neurological function
Subsequent Secondary Surgery Component of Success
no subsequent secondary surgical intervention at the index level
Device-Related SAE Component of Success
no device related serious adverse events
NDI - Change From Baseline
Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Neck Pain VAS Scores - Change From Baseline
Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Maximum Arm Pain VAS - Change From Baseline
Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Average Arm Pain VAS - Change From Baseline
Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Maximum Shoulder Pain VAS - Change From Baseline
Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Average Shoulder Pain VAS - Change From Baseline
Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Dysphagia Disability Index - Change From Baseline
Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Work Status Assessment
Return to Work
Estimated Proportion of Subjects Returning to Work
Activity
Clinical Assessment of Activity
Subject Satisfaction
Subject Satisfaction (Would you have this procedure again?)
Global Cervical Range of Motion - Change From Baseline
Average Radiographic Disc Height (mm) - Change From Post-op

Full Information

First Posted
February 5, 2007
Last Updated
September 19, 2017
Sponsor
DePuy Spine
search

1. Study Identification

Unique Protocol Identification Number
NCT00432159
Brief Title
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Official Title
A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2006 (Actual)
Primary Completion Date
May 1, 2013 (Actual)
Study Completion Date
May 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Spine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.
Detailed Description
This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Degenerative Disc Disease
Keywords
cervical, spinal, arthroplasty, disc, surgical, ACDF, DDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked.
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-level Cervical TDR
Arm Type
Experimental
Arm Description
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
Arm Title
1-level ACDF with plate
Arm Type
Active Comparator
Arm Description
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
Arm Title
2-level Cervical TDR
Arm Type
Experimental
Arm Description
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Arm Title
2-level ACDF
Arm Type
Active Comparator
Arm Description
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Arm Title
Training: 1 & 2-level Cervical TDR
Arm Type
Experimental
Arm Description
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Intervention Type
Device
Intervention Name(s)
Cervical TDR
Other Intervention Name(s)
cervical arthroplasty, cervical disc, c-TDR, DISCOVER disc
Intervention Description
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Intervention Type
Device
Intervention Name(s)
ACDF with plate
Other Intervention Name(s)
ACDF, Slim-Loc, Anterior cervical discectomy and fusion with plate
Intervention Description
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Primary Outcome Measure Information:
Title
Overall Success
Description
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
NDI Success
Description
15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Time Frame
24 months
Title
Neurological Component of Success
Description
no new clinically significant permanent abnormalities in neurological function
Time Frame
24 months
Title
Subsequent Secondary Surgery Component of Success
Description
no subsequent secondary surgical intervention at the index level
Time Frame
24 months
Title
Device-Related SAE Component of Success
Description
no device related serious adverse events
Time Frame
24 months
Title
NDI - Change From Baseline
Description
Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Time Frame
24 months
Title
Neck Pain VAS Scores - Change From Baseline
Description
Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Time Frame
24 months
Title
Maximum Arm Pain VAS - Change From Baseline
Description
Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Time Frame
24 months
Title
Average Arm Pain VAS - Change From Baseline
Description
Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Time Frame
24 months
Title
Maximum Shoulder Pain VAS - Change From Baseline
Description
Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Time Frame
24 months
Title
Average Shoulder Pain VAS - Change From Baseline
Description
Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Time Frame
24 months
Title
Dysphagia Disability Index - Change From Baseline
Description
Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
Time Frame
24 months
Title
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Description
Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Time Frame
24 months
Title
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Description
Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Time Frame
24 months
Title
Work Status Assessment
Time Frame
24 months
Title
Return to Work
Description
Estimated Proportion of Subjects Returning to Work
Time Frame
24 months
Title
Activity
Description
Clinical Assessment of Activity
Time Frame
24 months
Title
Subject Satisfaction
Description
Subject Satisfaction (Would you have this procedure again?)
Time Frame
24 months
Title
Global Cervical Range of Motion - Change From Baseline
Time Frame
24 months
Title
Average Radiographic Disc Height (mm) - Change From Post-op
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management Moderate Neck Disability Index (NDI) score Able to give informed consent for study participation Able and willing to return for all follow-up visits Key Exclusion Criteria: Significant cervical degenerative disc disease Prior fusion procedure at any level(s) (C1-T1) Marked cervical instability on lateral or flexion/extension radiographs Presence of systemic infection or infection at the surgical site Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing History of alcohol and/or drug abuse Any known allergy to a metal alloy or polyethylene Morbid obesity Any significant general illness (e.g., metastatic cancer, HIV)
Facility Information:
Facility Name
Olympia Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Sutter Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Rocky Mountain Associates in Orthopedic Medicine, PC
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Rush University/Midwest Orthopaedics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johnson County Spine
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States
Facility Name
Boston Spine Group
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02458
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Twin Cities Spine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. John's Regional Medical Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
St. Patrick Hospital Neurological Associates
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Nebraska Spine Center, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
Center for Diseases and Surgery of the Spine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
Southern NY Neurosurgical Group
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Upstate Medical College/SUNY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
Carolina Neurosurgery & Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Triangle Orthopaedic Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Neurospine Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
North Texas Spine Care at Baylor Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Pacific Private Clinic
City
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
St. Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

We'll reach out to this number within 24 hrs